AstraZeneca PLC's Fasenra failed to deliver statistically significant benefits to patients suffering from a type of lung disease, results from a late stage study of the drug showed.
The study, called Galathea, evaluated the safety and effectiveness of using Fasenra as an add-on treatment to inhaled therapies in patients with moderate to severe chronic obstructive pulmonary disease, or COPD. The disease is characterized by increasing breathlessness, and could manifest as emphysema, chronic bronchitis or refractory asthma.
"COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of Terranova and a full evaluation of both trials to determine next steps for Fasenra in COPD," said Sean Bohen, executive vice president, global medicines development and chief medical officer.
The Galathea trial's main goal was to reduce exacerbations — a sudden worsening of COPD symptoms such as shortness of breath, quantity and color of phlegm — in patients. The exacerbations typically last for several days and may be triggered by a viral or bacterial infection or by environmental pollutants.
Safety and tolerability data for Fasenra was consistent with previous results.
AstraZeneca said full data from the Galathea trial will be presented at a forthcoming medical meeting.
The phase 3 results from the Terranova study, meanwhile, is expected later this quarter.
Both trials are assessing the safety and effectiveness of using the treatment as an add-on to dual- or triple-inhaled therapy compared to placebo in patients with moderate to very severe COPD.
Fasenra, or benralizumab, is already approved as an add-on treatment for severe eosinophilic asthma in the U.S., EU, Japan and several other countries. AstraZeneca developed the respiratory biologic with its unit MedImmune, and in-licensed it with Japan's Kyowa Hakko Kirin Co. Ltd.
A biologic is a medicine manufactured in a living system such as a microorganism, or plant or animal cells, such as a complex protein like an antibody.